Drugs@FDA: FDA-Approved Drugs
Company: WEST-WARD PHARMS INT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | AP | No | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
03/28/2005 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076313ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/16/2022 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
09/16/2022 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
09/16/2022 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/27/2018 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
08/27/2018 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
01/02/2013 | SUPPL-8 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
03/03/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
INJECTABLE;INJECTION; EQ 0.05MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE PHARMS |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077457 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079198 | MYLAN INSTITUTIONAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090834 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076313 | WEST-WARD PHARMS INT |
SANDOSTATIN | OCTREOTIDE ACETATE | EQ 0.05MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019667 | NOVARTIS |
INJECTABLE;INJECTION; EQ 0.5MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216839 | GLAND PHARMA LTD |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE PHARMS |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077457 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079198 | MYLAN INSTITUTIONAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090834 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076313 | WEST-WARD PHARMS INT |
SANDOSTATIN | OCTREOTIDE ACETATE | EQ 0.5MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019667 | NOVARTIS |
INJECTABLE;INJECTION; EQ 0.1MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 216839 | GLAND PHARMA LTD |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 204669 | HERITAGE PHARMS |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075957 | MEITHEAL |
OCTREOTIDE ACETATE | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 217860 | SHUANGCHENG |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 077457 | FRESENIUS KABI USA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 079198 | MYLAN INSTITUTIONAL |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 090834 | SAGENT PHARMS INC |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076313 | WEST-WARD PHARMS INT |
SANDOSTATIN | OCTREOTIDE ACETATE | EQ 0.1MG BASE/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 019667 | NOVARTIS |